Lead R&D Quality Assurance

About the role

The Lead R&D Quality Assurance role is responsible for establishing a robust quality framework across the product development lifecycle. You will ensure that products, processes, analytical methods and technical documentation are developed following Quality by Design principles, regulatory requirements and internal standards while enabling rapid, scientifically rigorous technology transfer from R&D to manufacturing.

Key responsibilities

• Lead and manage the R&D Quality Assurance function, including team capability development and performance management.
• Establish and continuously improve the R&D Quality Management System, governing formulation, analytical, stability, scale‑up and technology‑transfer activities.
• Embed a Quality by Design and first‑time‑right mindset, driving high standards of scientific documentation, data integrity and development discipline.
• Provide quality oversight for specifications, SOPs, STPs, GTPs and other technical documentation, ensuring compliance with GLP, cGMP and data‑integrity standards.
• Drive right‑first‑time documentation practices, manage deviations, change controls, investigations and CAPA.
• Conduct risk‑based audits of laboratories, electronic records and development documentation.
• Oversee analytical and microbiology development practices, evaluate analytical risks and establish mitigation strategies.
• Lead quality governance of stability programs, including protocol review, sample management and OOS/OOT investigations.
• Provide quality leadership for technology transfer, establishing gates, readiness criteria and supporting multiple manufacturing sites.
• Partner with regulatory teams to ensure product, process and analytical compliance throughout development.

Required profile

• Master’s degree in Pharmacy or equivalent.
• 15–20 years of experience in R&D, manufacturing or corporate quality assurance, preferably in pharma or personal‑care products.
• Proven experience managing direct reports and collaborating with global, cross‑functional teams.
• In‑depth understanding of analytical practices and global regulatory requirements.

Required skills

• In‑depth understanding of analytical methods and practices.
• Knowledge of digital quality management tools, processes and systems.